GMPSOP

SEPTEMBER 27, 2023

A cleaning procedure must be in place before you can initiate cleaning validation for any product, equipment, or facility. At a minimum, the cleaning procedure should contain the following information: – Quantity and concentration of cleaning solution to be used. If it is not, analytical method validation is required.

Method Validation 98

Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

GMPSOP

JUNE 9, 2024

Test method validation in quality control Analytical Method Validation for Quality Control Test method validation generally means the same as analytical method validation, where the terms are interchangeable. Maintenance programs must be documented for laboratory equipment.

Method Validation 52

Method Validation Documentation Health and Personal Care Stores Labelling 52

Express Pharma

MAY 22, 2023

As the experts at this round table also discussed the need for such a centralised body, Srivastava, who was part of a meeting held by the Nutraceutical Task Force, informed that the formation of a nutraceutical panel in the Ministry of Commerce to ensure a nutraceutical industry-specific agenda is underway.

Dosage 105

Dosage Method Validation Labelling Immunization 105

GMPSOP

NOVEMBER 15, 2024

It should have the minimum information, such as general product information, specifications and test methodology, results, data analysis and estimated shelf life. With the appropriate detector sensitivity, column, and mobile phase, stability-indicating methods are very useful for determining degradant concentrations.

Packaging 59

Packaging Dosage Documentation Labelling 59

GMPSOP

JUNE 16, 2023

In this option, the RL has to assess all the risks and mitigate those risks by repeating the test parameters and matching the results against the original validation data. It’s essential to review the TL’s validation approach in accordance with current ICH Q2 guidelines and ensure that it covers the intended use of the method.

Documentation 52

Documentation Dosage Communication Method Validation 52

GMPSOP

OCTOBER 28, 2023

Validated test method A test method comprehensively describes all procedures used in sample analysis. Analytical test method validation guarantees that your test method is robust enough to provide evidence if your product meets the predetermined product specification or conforms to the failure of a product.

Documentation 52

Documentation Method Validation Packaging Data Entry 52